FDA approves APP enabled blood glucose monitoring system

Ascensia Diabetes Care announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the CONTOUR®NEXT ONE Blood Glucose Monitoring System (BGMS), marking a key step in making the next-generation system available to people living with diabetes in the U.S.

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Glycemic index is unreliable indicator of blood sugar response due to high variability

The glycemic index of a given food, a value that aims to quantify how fast blood sugar rises after eating it, can vary by an average of 20 percent within an individual and 25 percent among individuals, report scientists from the Jean Mayer USDA Human Nutrition Research Center on Aging (USDA HRNCA) at Tufts University.

In randomized, controlled, repeated tests involving 63 healthy adults, researchers found that individual blood sugar responses after consuming a fixed amount of white bread could range across all three glycemic index categories (low, medium, or high). Part of this variability could be attributed to insulin index and baseline HbA1c levels, which reflect long-term glucose control—evidence that glycemic index values are influenced by an individual’s metabolic responses to food.

“Glycemic index values appear to be an unreliable indicator even under highly standardized conditions, and are unlikely to be useful in guiding food choices,” said lead study author Nirupa Matthan, Ph.D., scientist in the Cardiovascular Nutrition Laboratory at the USDA HNRCA. “If someone eats the same amount of the same food three times, their blood glucose response should be similar each time, but that was not observed in our study. A food that is low glycemic index for you one time you eat it could be high the next time, and it may have no impact on blood sugar for me.”

Developed as a way to help diabetic individuals control their blood sugar, glycemic index is intended to represent the inherent effect a food has on blood sugar levels. However, glycemic index is becoming used for broader purposes such as food labeling, and has served as the basis for several popular diets.

To study whether glycemic index values are accurate and reproducible, Matthan and her colleagues recruited 63 volunteers, who underwent six testing sessions over 12 weeks. Volunteers fasted and abstained from exercise and alcohol before each session. They then consumed either white bread, a simple carbohydrate that served as the test food, or a glucose drink, which served as a reference control, in random order. Each contained 50 grams of available carbohydrate. Blood glucose levels were measured at multiple time points for five hours after eating, and glycemic index was calculated by standard formulas.

The team found that the average glycemic index value of white bread for the study population was 62, placing it in the category of a “medium” glycemic index food.

However, deviations averaged 15 points in either direction, effectively placing white bread in all three glycemic index categories. It would be considered a low glycemic index food (average values of 35 to 55) for 22 of the volunteers, intermediate glycemic index (57 to 67) for 23 volunteers, and high glycemic index (70 to 103) for 18 volunteers. Even within the same individual, glycemic index values could differ by more than 60 points between trials.

“Reports frequently tout the benefits of choosing foods with low glycemic index and glycemic load values. Our data suggest those values may not be reliable in terms of a daily intake. A better approach to choosing foods is to consume a diet primarily composed of vegetables, fruits, whole grains, nonfat and low-fat dairy products, fish, legumes (beans), lean meats with preference to preparing food with liquid vegetable oils, and equally as important, to choose healthy foods and beverages you really enjoy,” said senior study author Alice H. Lichtenstein, D.Sc., senior scientist and director of the Cardiovascular Nutrition Laboratory at the USDA HNRCA. Lichtenstein is also the Gershoff Professor at the Friedman School of Nutrition Science and Policy at Tufts.

The variability in glycemic index values occurred despite sample sizes larger than required by standard calculations. The study cohort of 63 individuals far exceeded the 10 individuals used by typical glycemic index methodology, as did the six feeding challenges and five-hour blood glucose measuring window.

The team also tested for the influence of biological characteristics: sex, body-mass index, blood pressure, physical activity, and several others. Most factors had only a minor statistical effect on glycemic index variability. Blood insulin response as measured by insulin index and HbA1c, a measure of longer term glucose control, had the largest effect, accounting for 15 and 16 percent of the variability, respectively.

The authors note their findings do not suggest that a high glycemic index food may be healthy, or that a low glycemic index food unhealthy. Both glycemic index and glycemic load—a value that adjusts glycemic index to serving size—reflect only food containing carbohydrates, and no one eats food in isolation. The high variability of glycemic index and glycemic load reveal limitations in their clinical and public health applicability, and glycemic index estimates and subsequent associations with chronic disease risk needs to be reconsidered, say the authors.

“Based on our results, we feel strongly that glycemic index is impractical for use in food labeling or in dietary guidelines at the individual level,” Matthan said. “If your doctor told you your LDL cholesterol value could vary by 20 percent, it would be the difference between being normal or at high risk for heart disease. I don’t think many people would find that acceptable.”

Source: Tufs University

 

 

Researchers Report Invention of Glucose-Sensing Contact Lens

Blood testing is the standard option for checking glucose levels, but a new technology could allow non-invasive testing via a contact lens that samples glucose levels in tears.

But glucose is a good target for optical sensing, and especially for what is known as surface-enhanced Raman scattering spectroscopy, said Shih, an associate professor of electrical and computer engineering whose lab, the NanoBioPhotonics Group, works on optical biosensing enabled by nanoplasmonics.

This is an alternative approach, in contrast to a Raman spectroscopy-based noninvasive glucose sensor Shih developed as a Ph.D. student at the Massachusetts Institute of Technology. He holds two patents for technologies related to directly probing skin tissue using laser light to extract information about glucose concentrations.

Full story is available from University of Houston website.

Abbott Diabetes Sensing Technology FDA Approved

Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the company’s FreeStyle Libre Pro system, a revolutionary continuous glucose monitoring (CGM) system for healthcare professionals to use with their patients with diabetes.

FreeStyle Libre Pro system is designed to empower healthcare professionals to provide better diabetes management for diabetes patients. The system provides healthcare professionals with a visual snapshot of glucose data, known as the Ambulatory Glucose Profile (AGP), giving a more simplified and clear overview of not only glucose levels, but also patterns and trends within those levels. This valuable information helps healthcare professionals make better, customized treatment decisions for their patients – and for a significantly lower cost than other professional CGM products availablei.

On nearly a daily basis, Eugene E. Wright, Jr., M.D. of Duke Southern Regional Area Health Education Center in Fayetteville, N.C., finds it challenging to effectively treat his patients with diabetes when it comes to decisions around insulin, nutrition and medication. “My patients are often out of range, due to inconsistent self-monitoring and insufficient data from traditional glucose meters that are unable to provide a full view of their glucose levels.”

A press release is availble from Abbott website.

Roche launches innovative Accu-Chek Guide blood glucose monitoring systemGuide blood glucose monitoring system

Roche launches of the Accu-Chek® Guide, the next-generation blood glucose monitoring system. This new system is designed to make everyday blood glucose (BG) monitoring easier with features such as the spill-resistant SmartPack test strip vial, which helps users to remove just one strip at a time and avoid spillage or contamination. The Accu-Chek Guide system also provides for advanced accuracy, which enables reliable diabetes management. “As the global leader in diabetes management we are dedicated to supporting people with diabetes, in thinking less about their daily therapy routines. We are very excited to introduce this innovative system, that simplifies blood glucose monitoring and improves the testing experience,” said Roland Diggelmann, CEO Roche Diagnostics. First markets to launch the new system are Denmark, Switzerland and Australia. Morecountries will follow subsequently starting in early 2017.

The Accu-Chek Guide system enables on-board pattern detection that helps to increase awareness of too high or too low glucose readings as well as Bluetooth Low Energy connectivity to the Accu-Chek Connect diabetes management solution via a mobile app. This cloud-based solution guarantees a secure online data exchange and automatic data logging. People with diabetes, caregivers, and healthcare providers can share diabetes information virtually anywhere for timely advice and remote monitoring. Such telemedicine solutions can help people with diabetes and their caregivers manage diabetes more efficiently and give them peace of mind and a feeling of relief. Hence, 97% of 197 participants in a recently published study from France and the US agreed that the system was very easy to use and offers a better testing experience.

The Accu-Chek Guide system not only fulfills current accuracy standards but delivers even tighter 10/10 accuracy for more reliable results3. Consistently accurate measurements are essential for reliable BG monitoring and deriving the correct therapy decisions. Large deviations of the measured BG values from the true glucose levels can result in higher HbA1c levels, glycemic excursions and markedly increased rates of hypoglycemic events, as a recently published retrospective study revealed. In addition, studies have demonstrated that only about half of the BG meters evaluated meet the minimum accuracy requirements as defined by the ISO 15197:2013/EN ISO 15197:2015 Standard.

A press release can be found from Roche Website.

World’s First Bluetooth Insulin Pen

Emperra GmbH is launching the world’s first Bluetooth® insulin pen on the market and therefore expanding its ESYSTA® product system’s function. The new ESYSTA® BT pen is equipped with a Bluetooth® interface and transfers the injected insulin doses directly to the patient’s digital blood glucose diary. The smart insulin pens automatically connected via the 868 MHz interface (similar to the ISM band) are already being successfully used in medicine in combination with a wireless transmission blood glucose meter as an integrated diabetes management system, ESYSTA®. Both the hardware components and software solutions (ESYSTA® portal, ESYSTA® app) have been certified as CE-compliant medical products. Patients and doctors can achieve a new quality of medical care for Type 1 and Type 2 diabetics using the patented ESYSTA® solution. On the basis of the available scientific data and reimbursement by statutory health insurance companies on the complex German healthcare market, Emperra is striving to use this smart insulin pen based ESYSTA® telemonitoring solution with an FDA filing process for the US market. FDA clearance is expected in 2016.

Product information is available from Emperra GmbH website.